Royalty Report: Drugs, Cancer, Disease – Collection: 3000

License Grant

The Licensee has acquired exclusive rights from the Licensor to antisense oligonucleotides directed against the Bcl-2 mRNA, as well as methods of their use for the treatment of cancer. The claims of the Licensor patents cover our proprietary antisense oligonucleotide molecules, which target the Bcl-2 mRNA, including Genasense®, and methods of using them.

Field of Use

The Licensee is a biopharmaceutical company engaged in pharmaceutical research and development and dedicated to the identification, development and commercialization of novel drugs for the treatment of cancer and related diseases.

License Grant

For the exclusive grant to commercialize, Licensor grants an exclusive right and license to practice under the Licensor patent rights, and to use, reproduce, modify and otherwise exploit the Licensor Technology, in each case only to sell, offer for sale and import compound and product into and throughout the United States for use in the field.

For the exclusive grant to manufacture, Licensor grants an exclusive right and license to practice under the Licensor patent rights, and to use, reproduce, modify and otherwise exploit the Licensor technology, in each case only to make and use compound and product in the field.

For the grant to conduct research and development,  Licensor grants a co-exclusive right and license, along with Licensor and its Affiliates, to practice under the Licensor patent rights, and to use, reproduce, modify and otherwise exploit the Licensor technology, in each case only to make, but not have made, use and import, but not sell or offer for sale, other compounds and other products solely for research and development purposes.

For the trademarks and copyrights, Licensor grants an exclusive license to use the product trademark and the Licensor house-marks on and in connection with the marketing, sale, advertising and/or promotion of the product in the United States, and thereafter on a non-exclusive basis during the Trailing Period.

License Property

Licensor has developed an antisense compound known as oblimerosen sodium that downregulates the production of Bc1-2 and potentially other targets.

BCL-2 shall mean the species and sequence of the messenger RNA (mRNA) or the pre-message thereof, encoded by the Bel lymphoma-2 (Bcl-2) gene, that generates a Bcl-2 protein, and any and all isoforms thereof.

CLL shall mean chronic lymphocytic leukemia.

The product trademark is Genasense.

Field of Use

The field shall mean all human therapeutic uses.  The product Therapeutic Claim is for the Treatment of cancer and rheumatological diseases, an antisense oligonucleotide.

License Grant

For the exclusive grant to commercialize, Licensor grants to the Licensee of Ireland, an exclusive right and license to practice under the Licensor patent rights, and to use, reproduce, modify and otherwise exploit the Licensor Technology, in each case only to sell, offer for sale and import compound and product outside the United States for use in the field.

For the exclusive grant to manufacture, Licensor grants an exclusive right and license to practice under the Licensor patent rights, and to use, reproduce, modify and otherwise exploit the Licensor technology, in each case only to make and use compound and product in the field.

For the grant to conduct research and development,  Licensor grants a co-exclusive right and license, along with Licensor and its Affiliates, to practice under the Licensor patent rights, and to use, reproduce, modify and otherwise exploit the Licensor technology, in each case only to make, but not have made, use and import, but not sell or offer for sale, other compounds and other products solely for research and development purposes.

For the trademarks and copyrights, Licensor grants an exclusive license to use the product trademark and the Licensor house-marks on and in connection with the marketing, sale, advertising and/or promotion of the product outside the United States, and thereafter on a non-exclusive basis during the Trailing Period.

License Property

Licensor has developed an antisense compound known as oblimerosen sodium that downregulates the production of Bc1-2 and potentially other targets.

BCL-2 shall mean the species and sequence of the messenger RNA (mRNA) or the pre-message thereof, encoded by the Bel lymphoma-2 (Bcl-2) gene, that generates a Bcl-2 protein, and any and all isoforms thereof.

CLL shall mean chronic lymphocytic leukemia.

The product trademark is Genasense.

Field of Use

The field shall mean all human therapeutic uses.  The product Therapeutic Claim is for the Treatment of cancer and rheumatological diseases, an antisense oligonucleotide.

License Grant

Licensor shall manufacture API for Licensee for both world-wide commercial purposes and clinical purposes.

Licensor grants a non-exclusive, perpetual and irrevocable, worldwide right and license to practice under the Licensor Patent Rights and thereafter use, sell, offer for sale and import such products.

License Property

The patents are used to make or have made any oligonucleotide owned or controlled by Licensee, including without limitation API.

API or Active Pharmaceutical Ingredient is known as oblimersen sodium, that certain all-phosphorothioate oligonucleotide consisting of 18 modified nucleic acid bases.

Field of Use

The Licensee's lead investigational antisense drug is called Genasense(TM) (oblimersen sodium), a molecule that is designed to block the production of a protein known as Bcl-2. Current science suggests that Bcl-2 is a fundamental (although not sole) cause of the inherent resistance of cancer cells to current anticancer treatments, such as chemotherapy, radiation, or monoclonal antibodies. While Genasense(TM) has displayed some anticancer activity when used by itself, the Licensee is developing the drug solely as a means of amplifying the effects of other anticancer therapy by pre-treating patients with Genasense(TM).

License Grant

For the Exclusive License,  Licensor grants an exclusive, worldwide license, with the right to sublicense, to Licensor Intellectual Property that relates to a Joint p53-PMO Item, solely in the Licensee Field, to research, develop, make, have made, use, import, put into use, modify, distribute, offer for sale, sell and have sold Licensed Licensor IP Products and to practice Licensed Licensor IP Methods during the term of this Agreement.

For the Semi-Exclusive License, Licensor shall grant a semi-exclusive, worldwide license to Licensor Intellectual Property that relates to a Joint p53-PMO Item, solely in the Joint Field and within the context of such joint development activities with Licensor, to research, develop, make, have made, use, import, put into use, modify, distribute, offer for sale, sell and have sold Licensed Licensor IP Products and to practice Licensed Licensor IP Methods during the term of this Agreement.

License Property

The patents licensed include Antisense Oligonucleotides to p53, and, Methods and compositions for selectively treating cancer cells characterized by p53 expression, and, Therapeutic Oligonucleotides targeting human MDR-! and MRP Genes, and, Methods and compositions for treatment of cancer using Oligonucleotides, and, Methods and Compositions for Cellular Reprogramming.

p53 is a protein.  PMO refers to  phosphorodiamidate morpholino oligomer chemistry.

Antisense drugs targeting p53 is a well-studied human protein that controls cellular response to genetic damage.

Field of Use

Licensees main field of interest in p53-PMO technology is as a potential target for antiviral therapies, and the Parties wish to cooperate in the development and commercialization of therapies using p53-PMO technology in other fields.

License Grant

Licensor grants to the Canadian Licensee an exclusive, worldwide license under the Licensor Product-Specific Technology Patents and the Joint Patents to any Product-Specific Technology and under the Licensor Core Technology Patents, in each case solely to develop, make, have made, use, sell, offer for sale, have sold and import Products.

License Property

Licensor is a biopharmaceutical company exploiting proprietary RNA-based drug discovery technologies to identify and commercialize novel drugs.

Antisense Compound means an oligomeric compound or analog, mimic or mimetic thereof having a sequence that is partially or wholly complementary to the sequence of a messenger RNA (pre-mRNA or mRNA), viral RNA, or noncoding RNA that directly modulates RNA expression.

Product means a pharmaceutical preparation comprising any single TS ASO or Tandem selected by Licensee. After the Project Plan has been completed, the Parties will append to this Agreement the specific sequence and chemistry of each TS ASO which constitutes the active pharmaceutical ingredient in each Product.

TS ASO means a single-stranded oligonucleotide or an analog thereof that hybridizes to TS mRNA using Watson-Crick base pairing and inhibits production of TS via an RNase-H mechanism.

1. U.S. Patent No. 6,001,1653
2. PCT Publication No. WO 93/13121
3. U.S. Patent. 5,914,396
4. U.S. Patent 61451,991
5. U.S. Patent No. 6,166,197
6. U.S. Patent No. 51919,619
7. U.S. Patent No. 5,962,425
8. U.S. Patent No. 6,143,881
9. U.S. Patent No. 5,969,116
10. U.S. Patent No. 6,346,614
11. U.S. Patent No. 6,399,754
12. U.S. Patent No. 6,326,199

Field of Use

The field of use is the identification of a lead TS ASO targeted to inhibit Thymidylate Synthase.

The drug is an antisense inhibitor of thymidylate synthase (TS), a well-known drug target that protects cancer cells from the effects of several chemotherapy treatments. In preclinical studies, antisense inhibition of TS suppressed human tumor cell growth and overcame tumor cell resistance to marketed TS-targeted drugs.

TS is an important target in a wide variety of cancers including, colorectal, breast, stomach, esophageal, head and neck cancers, and mesothelioma; it is of increasing importance in non-small cell lung cancer. In addition to interfering with the effectiveness of chemotherapy, the TS gene may also participate in causing cancer. TS is a target for several chemotherapy agents, including 5-fluorouracil (5-FU), pemetrexed (Alimta®), and raltitrexed (Tomudex®).